Technical Writer - Operations

SUMMARY/OBJECTIVE:

The Technical Writer is responsible for leading Quality Management System (QMS) documentation activities within Operations. This role will partner closely with Manufacturing, Packaging, Warehouse, Facilities, and Quality Assurance teams to draft, revise, route, and maintain controlled documentation in support of compliant GMP operations. This position serves as a key liaison between Operations and Quality Assurance. The role requires strong technical writing skills, attention to detail, organizational abilities, and familiarity with cGMP documentation practices in a regulated CDMO environment.

ESSENTIAL DUTIESAND RESPONSIBILITIES:

• Leads deviation and complaint Root Cause Analysis and CAPA development for GMP investigations.
• Leads change control documentation activities related to Operations.
• Drafts, revises, formats, and coordinates controlled GMP documentation including:
• SOPs
• Batc...